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The FDA warned Raritan Pharmaceuticals for violating GMP standards, noting the firm failed to properly test its products, which are meant for vulnerable populations, or to maintain good quality control practices. Read More
Takeda subsidiary Millennium Pharmaceuticals called on the FDA to withhold approval for generic versions of its drug Velcade (bortezomib) until at least next February, when a relevant exclusivity period expires. Read More
The FDA surpassed many of its performance goals for generic drug applications through 2016, but the agency needs a plan for the user fees collected but not spent in the same year, according to the GAO. Read More
The FDA implemented a new policy to expedite generic drug reviews in areas of limited competition, and published a list of off-patent branded drugs with no approved alternatives, as the first steps in the agency’s action plan to help lower the costs of prescription drugs. Read More